Drug appeared to neither help nor harm COVID-19 patients

THE LARGEST STUDY to date of hydroxychloroquine, the antimalarial drug touted by President Trump as a potential “game-changer” in the treatment of coronavirus, found no evidence of a benefit in treating severely ill COVID-19 patients.

The study, published Thursday in the New England Journal of Medicine, looked at the drug’s effect on COVID-19 patients admitted to New York–Presbyterian Hospital–Columbia University Irving Medical Center from early March through early April.

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Researchers examined whether the drug reduced patients’ risk of dying or becoming so sick they had to be intubated and put on a ventilator, and concluded “the risk of intubation or death was not significantly higher or lower among patients who received hydroxychloroquine than among those who did not.”

The study was not a randomized trial — the type of controlled experiment considered the gold standard for determining the effect of a drug. Instead, it was an observational study, meaning doctors were free to make their own judgment of whether to treat patients with hydroxychloroquine or not.

Of the 1,376 patients included in the study, 59 percent were treated with the antimalarial drug and 41 percent were not. The patients given the drug were more severely ill than those not receiving it, a difference the researchers accounted for in their analysis along with adjusting for other factors that may have differed between the two groups.

Although it is not approved by the Food and Drug Administration to treat COVID-19, hydroxychloroquine has received “emergency use authorization” from the FDA to be used in hospitals while study results are pending.

The researchers said they could not rule out a benefit or harm of the drug, “but the results do not support the use of hydroxychloroquine at present, outside randomized clinical trials testing its efficacy.” As a result of their study findings, they wrote, “clinical guidance at our medical center has been updated to remove the suggestion that patients with Covid-19 be treated with hydroxychloroquine.”

“We hoped that with our statistical techniques we’d be able to detect a big outcome and we don’t detect that,” said Dr. Joshua Geleris, lead author of the study, which was funded by the National Institutes of Health. “If there was a small benefit or harm we may not be able to detect it.”

Trump has repeatedly promoted the idea that hydroxychloroquine could be an effective treatment for coronavirus patients, calling it a potential “game-changer” and saying at one point last month that he might consider taking it himself, despite having twice tested negative for the virus at that point.

Two very small randomized trials in China, one enrolling 62 patients and one 30 patients, suggested possible benefits from hydroxychloroquine. A trial of 440 patients in Brazil, which tested two dose levels of hydroxychloroquine, was stopped when the higher dose appeared to be linked to dangerous cardiac EKG changes and higher mortality.

Several more large randomized trials are underway in the US, including one directed by doctors at Mass. General Hospital and another being coordinated at the San Francisco VA Health Care System.

“We need a randomized trial to really tell what impact, if any, the drug has,” said Geleris, an internist and assistant professor of medicine at Columbia University Medical Center.

Hydroxychloroquine has been shown in laboratory studies to have antiviral properties, but its effect on COVID-19 patients is unclear. Dr. Anthony Fauci, the federal government’s leading infectious disease official, has urged restraint in touting possible coronavirus treatments before they are rigorously tested in well-controlled trials.

About Michael Jonas

Michael Jonas has worked in journalism in Massachusetts since the early 1980s. Before joining the CommonWealth staff in early 2001, he was a contributing writer for the magazine for two years. His cover story in CommonWealth's Fall 1999 issue on Boston youth outreach workers was selected for a PASS (Prevention for a Safer Society) Award from the National Council on Crime and Delinquency.

Michael got his start in journalism at the Dorchester Community News, a community newspaper serving Boston's largest neighborhood, where he covered a range of urban issues. Since the late 1980s, he has been a regular contributor to the Boston Globe. For 15 years he wrote a weekly column on local politics for the Boston Sunday Globe's City Weekly section.

Michael has also worked in broadcast journalism. In 1989, he was a co-producer for "The AIDS Quarterly," a national PBS series produced by WGBH-TV in Boston, and in the early 1990s, he worked as a producer for "Our Times," a weekly magazine program on WHDH-TV (Ch. 7) in Boston.

Michael lives in Dorchester with his wife and their two daughters.

About Michael Jonas

Michael Jonas has worked in journalism in Massachusetts since the early 1980s. Before joining the CommonWealth staff in early 2001, he was a contributing writer for the magazine for two years. His cover story in CommonWealth's Fall 1999 issue on Boston youth outreach workers was selected for a PASS (Prevention for a Safer Society) Award from the National Council on Crime and Delinquency.

Michael got his start in journalism at the Dorchester Community News, a community newspaper serving Boston's largest neighborhood, where he covered a range of urban issues. Since the late 1980s, he has been a regular contributor to the Boston Globe. For 15 years he wrote a weekly column on local politics for the Boston Sunday Globe's City Weekly section.

Michael has also worked in broadcast journalism. In 1989, he was a co-producer for "The AIDS Quarterly," a national PBS series produced by WGBH-TV in Boston, and in the early 1990s, he worked as a producer for "Our Times," a weekly magazine program on WHDH-TV (Ch. 7) in Boston.

Michael lives in Dorchester with his wife and their two daughters.

Asked whether he hoped the new study findings would temper Trump’s speculative hyping of the antimalarial drug, Geleris said, “I’m not sure I can speak to the political or health policy implications of the study. I’ll speak to what we published.”